Development Challenges

Too Many Meetings, Emails, Status Updates

In Your Words

“Getting people to respond to emails.”
“Tracking component status to support product builds.”
“Correcting poor virtual development documentation.”

Manual Development Process Dominates

The use of specialized medical device development tools has increased by 25% since 2016. The majority of teams, however, still manage work with a combination of Word documents and spreadsheets.

According to the survey:

65% use Microsoft Word to manage requirements.

65% use Microsoft Excel to manage test cases.

59% use Microsoft Excel to manage and track issues.

As we can see, teams with a predominantly manual process dedicate time to daily project administrative work.

Good ALM tools can streamline much of the manual processes and free up time for higher priority work.

Collaboration Challenges in Embedded Development

Cross-team collaboration was the number one challenge for development teams building embedded devices. The rise of distributed teams is impacting organizations everywhere. It's also affecting modern device designers.

Teams developing products with hardware and software often work in disparate systems. This disconnect can stall collaboration among designers, hardware engineers, and coders.

More and more, companies find talent where it lives rather than bring it all together into one office. To work across geographic and time zone boundaries, teams need an accessible system that provides a secure, reliable single source of truth for managing assets, no matter where they sit.

The right tooling — a version control system with proper integrations, for example — can ease many of these asset challenges.

The Proof Is in the Documentation

Proving compliance is never simple. For those involved in the process, three challenges shared top spots: documentation, objective evidence, and risk & hazard analysis.

Documentation, objective evidence, and risk and hazard analysis top the list.

These results should not surprise anyone with a manual development process. When teams need proof, they have to dive into documentation to make all the necessary connections. Objective evidence, for instance, can be buried (or worse: lost) in spreadsheets. A more formalized documentation & testing process, a robust test management tool, or a combination of both can help greatly.

Few Focused On Coding Standards

A surprising majority, 75% of respondents, either aren’t using a coding standard or are unaware if the team is even applying one.

Coding standards help reduce risk by ensuring the development team is conforming to a shared set of industry requirements. Static code analysis can play a pivotal role.

Industry Future

Technologies unheard of as recently as a decade ago are finding a place on product roadmaps.

Key Drivers of Innovation

What will spur innovation? Industry leaders believe the answer lies in simplified regulations, unified standards, and more investment in R&D.

Simpler Standards & Regulations — Down From 2018

It appears some progress has been made in improving innovation despite the overhead of industry standards and regulations.

Innovation Demands More R&D

Today’s technological landscape offers opportunities to capitalize on innovation. But incorporating these innovations into design requires more investment in R&D. A majority are either currently working on or planning to include emerging tech in product design.

Regulations on the Radar

It’s no surprise. Many are watching the European Union Medical Device Regulations (MDR) scheduled to take effect on May 25, 2020.

FDA regulations are second. After that, developers are concerned with ISO 13455:2016 (for quality management systems). They’re also watching revisions to ISO 14971, which requires a well-documented narrative of the product lifecycle.

What’s Next?

Will hybrid Agile development continue to be the preferred process for medical device developers? Will device developers address manual processes? How exactly will the increase in emerging technologies impact how teams collaborate?

How Helix ALM Helps

Have comments or suggestions for next year’s report? Share with us by emailing [email protected] with subject line “Med Dev 2020.”

ABOUT THE SURVEY

Perforce surveyed 267 medical device professionals in February 2019. Participants represented a wide range of experience. From industry veterans with 10+ years of experience in the upper tiers of management to development professionals with under a year of experience. Survey respondents also represented a diverse range of device types (hardware, software, both), and classes (I, II, III, IV, De Novo).